Follow-on intravenous iron formulations in haemodialysis patients

Non‐Biological Complex Drugs/Research | Posted 01/04/2016 post-comment0

A study into the efficiency of follow-on intravenous (IV) iron formulations compared to originator formulations in haemodialysis patients has shown the follow-on products to be less efficient at maintaining the same haemoglobin levels [1].

Haemodialysis V15a16 2

Anaemia is a common complication of chronic kidney disease (CKD) and has been associated with adverse clinical outcomes. It has a complex pathogenesis and mainly arises due to inadequate erythropoietin production, insufficient iron storage, inflammation, vitamin B12 and folic acid depletion, severe secondary hyperparathyroidism and blood loss during the haemodialysis procedure. The use of IV iron to treat renal anaemia is increasing and can be used to address low haemoglobin levels in CKD patients.

This observational study included 342 patients and compared the same measurements that were collected prospectively before and after a switch from a follow-on IV iron to an originator IV iron in a cohort of stable haemodialysis patients. The follow-up period was 56 weeks for each formulation. Anaemia parameters and doses of erythropoiesis-stimulating agents (ESA) and IV iron were prospectively recorded before and after the switch from follow-on to originator IV iron.

To maintain the same haemoglobin levels after switching from the follow-on to the originator formulation, the requirements for IV iron doses were reduced by 34.3% (from 52.8 ± 33.9 to 34.7 ± 31.8 mg/week, p < 0.001) and the ESA doses were also decreased by 12.5% (from 30.6 ± 23.6 to 27 ± 21 μg/week, p < 0.001). The erythropoietin resistance index declined from 8.4 ± 7.7 to 7.4 ± 6.7 IU/kg/week/g/dL after the switch from the follow-on to the originator drug (p = 0.001). After the switch, the transferrin saturation ratio (TSAT) and serum ferritin levels rose by 6.8% (p < 0.001) and 12.4%(p = 0.001), respectively. The mortality rate was similar for both periods and the haemoglobin levels were stable throughout the study (26 months).

The results suggest that a change from the follow-on to the originator iron formulation can be made safely as long as the doses are adjusted.

The authors concluded that the iron and ESA requirements were lower with the originator IV iron compared to the follow-on drug. In addition, use of the originator formulation resulted in higher ferritin and TSAT levels despite the lower dose of IV iron.’ They added that ‘further studies are necessary to analyse the adverse effects of higher IV iron dosages.’

Conflict of interest
The authors of the research paper [1] declared that there were no conflicts of interest.

Editor’s comment
Readers interested to learn more about non-biological complex drugs are invited to visit to view the following manuscript published in GaBI Journal:

Non-Biological Complex Drugs (NBCDs) and their follow-on versions: time for an editorial section

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Related article
Regulations for follow-on NBCDs

1.    Agüera ML, et al. Efficiency of original versus generic intravenous iron formulations in patients on haemodialysis. PLoS One. 2015 Aug 31;10(8):e0135967

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